Pharmaceutical Product Licensing: Requirements for Europe

Author:   Brian R. Matthews ,  Anthony C. Cartwright
Publisher:   Taylor & Francis Ltd
ISBN:  

9780136628835


Pages:   328
Publication Date:   31 May 1991
Format:   Hardback
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

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Pharmaceutical Product Licensing: Requirements for Europe


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Full Product Details

Author:   Brian R. Matthews ,  Anthony C. Cartwright
Publisher:   Taylor & Francis Ltd
Imprint:   Taylor & Francis Ltd
Dimensions:   Width: 17.40cm , Height: 2.10cm , Length: 24.60cm
Weight:   0.453kg
ISBN:  

9780136628835


ISBN 10:   0136628834
Pages:   328
Publication Date:   31 May 1991
Audience:   Professional and scholarly ,  General/trade ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

Table of Contents

Introduction and history of licensing requirements; new active substance products - quality requirements; new active substance products - pre- clinical requirements; new active substance products - clinical requirements; abridged applications; drug master files; biological products; radiopharmaceutical products; medicated devices; contact lens products; experts and expert reports; defects in applications - analysis; CPMP and its activities; CPMP multi-state procedure; high EFTA EEC

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Cartwright, A. C.; Cartwright, A. C.

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